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CTRI Number  CTRI/2021/08/035755 [Registered on: 18/08/2021] Trial Registered Prospectively
Last Modified On: 24/11/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Comparative study of Ashwagandha for its effect on quality of life in patients during post-COVID19 period 
Scientific Title of Study   Evaluation of Ashwagandha (Withania Somnifera) Standardized Extract for its effect on quality of life (QoL) in patients during post-COVID19 period: A Prospective, Randomized, Placebo-Controlled Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
DYP-Pharm-RP-22; Version 1,dt. 29/05/21  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abhay Uppe 
Designation  Professor and Head of Unit, Pulmonary Medicine 
Affiliation  D Y Patil Medical College, Hospital and Research Center  
Address  Department of Pulmonary Medicine, D Y Patil UNiversity School of Medicine & Hospital Sector-5, Nerul, Navi Mumbai Thane MAHARASHTRA

Thane
MAHARASHTRA
400706
India 
Phone  9769319554  
Fax    
Email  abhay.uppe@dypatil.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Deepak Langade 
Designation  Professor and Head, Pharmacology 
Affiliation  D Y Patil Medical College, Hospital and Research Center  
Address  Department of Pharmacology 5th floor D Y Patil UNiversity School of Medicine & Hospital Sector-5, Nerul, Navi Mumbai Thane MAHARASHTRA

Thane
MAHARASHTRA
400706
India 
Phone    
Fax    
Email  deepak.langade@dypatil.edu  
 
Details of Contact Person
Public Query  
Name  Dr Deepak Langade 
Designation  Professor and Head, Pharmacology 
Affiliation  D Y Patil Medical College, Hospital and Research Center  
Address  Department of Pharmacology 5th floor D Y Patil UNiversity School of Medicine & Hospital Sector-5, Nerul, Navi Mumbai Thane MAHARASHTRA


MAHARASHTRA
400706
India 
Phone    
Fax    
Email  deepak.langade@dypatil.edu  
 
Source of Monetary or Material Support  
Ixoreal Biomed Inc., Shri Kartikeya Pharma 5-9-225, Sanali Estate, Abids, Hyderabad - 500001 
 
Primary Sponsor  
Name  D Y Patil Medical College Hospital and Research Center 
Address  D Y Patil UNiversity School of Medicine & Hospital Sector-5, Nerul, Navi Mumbai Thane MAHARASHTRA 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Abhay Uppe  D Y Patil Medical College, Hospital and Research Center  Department of Pulmonary Medicine, D Y Patil UNiversity School of Medicine & Hospital Sector-5, Nerul, Navi Mumbai
Thane
MAHARASHTRA 		 9769319554

abhay.uppe@dypatil.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC), Padmashree Dr D Y Patil Medical College, Hospital and Research Center, Navi Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Product  300 mg Placebo capsule identical to KSM 66 Ashwagandha but without active ingredients, twice a day for 12 weeks 
Intervention  Test Product  KSM 66 Ashwagandha Capsule (300 mg), twice a day for 12 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Subjects of either gender, aged 18 to 50 years
2. All adult patients aged ≥18 years who present to the site for follow-up OPD
3. Laboratory-confirmed COVID-19 infection with SARS-CoV-2
4. Patients who agree to follow-up for up to three months.
5. Subjects able to understand and complete the study questionnaires
6. Subjects who sign the informed written consent 
 
ExclusionCriteria 
Details  1. Patients aged below 18 years will be excluded.
2. Unwilling or unable to provide written informed consent,
3. Pregnant or breast-feeding women or women with positive urinary pregnancy test at screening.
4. Those who cannot be relied upon to comply with the test procedures or are unwilling to give
informed consent 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in the health summary scores from Short Form SF-36 Quality of life (SF-36 QoL)questionnaire at the end of 12 weeks   screening, week 4, week 8 and week 12  
 
Secondary Outcome  
Outcome  TimePoints 
Change in scores for HAM-A at the end of 12 weeks  screening, week 4, week 8 and week 12  
Change in scores for HAM-D at the end of 12 weeks  screening, week 4, week 8 and week 12 
Changes in Cardio-Pulmonary Exercise Testing (CPET) results at the end of 12 weeks  screening and week 12 
 
Target Sample Size
Modification(s)  		 Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "52"
Final Enrollment numbers achieved (India)="52" 
Phase of Trial   N/A 
Date of First Enrollment (India)   21/08/2021 
Date of Study Completion (India) 04/04/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   A Prospective, Randomized, Placebo-Controlled Study of Ashwagandha Standardized Extract (KSM66) for its effect on quality of life (QoL) in patients during post-COVID19 period.
COVID-19 is a disease caused by the SARS-CoV-2 virus. It infects the respiratory tract. Some people who get COVID-19 have only mild symptoms. But for others, infection leads to pneumonia, respiratory failure, and, in some cases, death. Researchers want to learn more about any potential beneficial effects of ashwagandha in people who recover from COVID-19.The purpose of this study is to evaluate any potential benefits of Ashwagandha in patients who have recovered from COVID-19 in improving their overall quality of life.
The study assessments to be done by SP-36, Hamilton anxiety Rating scale (HAM-A) ,HAM-D throughout the study period till week 12 and CareFusion Vyntus CPX metabolic system (CareFusion Germany 234 GmbH) at screening and week 12.
 
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